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Comparison of Safety and Efficacy of Needle-Free Injector and Insulin Pen in Patients With T2DM

NCT04682795 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-09-01

No results posted yet for this study

Summary

In this prospective, multi-center, randomized, open-label, parallel group trial, the safety and efficacy of needle-free injector will be compared with insulin pen after 2 weeks of treatment in patients with type 2 diabetes. This trial will enable assessment of the clinically relevant endpoint of a change in Time in Range (TIR), a newly recommended measurement of blood glucose fluctuations.

Conditions

  • T2DM (Type 2 Diabetes Mellitus)
  • Needle-free Injector
  • Time in Range

Interventions

DEVICE

Needle-free injector

Using needle-free injector as insulin carrier to treat T2DM

DEVICE

Insulin pen

Using insulin pen as insulin carrier to treat T2DM

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04682795 on ClinicalTrials.gov